Your DCB 0129 safety case,
from scope to sign-off.
I help digital health teams prepare clinical safety evidence. Scope, deliverables and fee agreed before work starts.
Scope. Hazards. Evidence.
A clear route from intended use to a documented clinical-safety review.
- 01 / Define
Agree the scope
Product, intended use and responsibilities.
Scope details
Manufacturer-side DCB 0129 and deployment-side DCB 0160 work are scoped separately. I check applicability before agreeing an engagement.
Compare the responsibilities → - 02 / Review
Trace the risks
Hazards, controls and supporting evidence.
Review details
I connect clinical workflows to the hazard log, safety requirements and evidence for the agreed product and release.
The evidence package → - 03 / Document
Review the case
Sign-off only where the evidence supports it.
Decision boundaries
Clinical-safety review is not regulatory approval. The deploying organisation retains its own deployment decision and DCB 0160 responsibilities.
Independent CSO support →
What you get.
A clinical safety evidence package for the agreed product and release. I sign off the safety case only when the evidence supports it.
What the package includes
Clinical Safety Case Report
01 · Included
DCB 0129-conformant CSCR: intended use, scope, safety claims, hazard summary and residual risk justification. Written and evidenced the way clinical safety committees expect to see it.
Product-specific report CSCR and hazard log details →Hazard log & Clinical Risk Management File
02 · Included
Full CRMF with hazard identification workshop, risk evaluation matrix, mitigation traceability, and pre/post-mitigation risk scores. Maintained as a live document.
Scope-led hazard analysisSafety requirements specification
03 · Included
Engineering-actionable safety requirements, mapped to your hazards. Your dev team gets a clear backlog; your auditor gets traceability.
JIRA / Linear-readyGo-live release memo
04 · Included
A documented CSO review of residual clinical risk for the agreed release, signed where the evidence supports it. The deploying organisation makes its own deployment decision.
Signed by CSOPost-market surveillance plan
05 · Included
A written plan for post-deployment clinical safety monitoring: incident review, escalation triggers and review frequency, aligned with your product and responsibilities. Running the surveillance and reviewing safety after go-live is a separate engagement — see below.
Plan documentDTAC and DSPT cross-walk
06 · Hourly
If you also need DTAC or DSPT (most do), I'll map your DCB outputs to those frameworks so you don't duplicate work.
£125 / hr DTAC clinical safety support →How the fixed fee works
Why the fee is the fee.
£6,000 covers an agreed DCB 0129 safety case package, with clinical review and sign-off where the evidence supports it. Here is what that price actually covers.
A name on the line
Your safety case is reviewed by a doctor with NHS clinical experience and a Clinical Safety Officer. The CSO makes and documents the clinical safety judgement; the manufacturer and deploying organisation retain their own risk acceptance and release responsibilities.
Written from the clinic floor
I bring clinical experience to hazard analysis and work with your users and subject-matter experts to understand the relevant pathway. Controls must fit how the product will actually be used.
A fixed fee that protects your runway
One number, agreed up front, for the defined pre-go-live package. The £6,000 fixed fee covers the agreed scope, with a four-week target confirmed after reviewing the product, evidence and team availability.
A four-week target
The target is four weeks from an agreed kickoff, with timely access to your team and evidence. Unresolved hazards, missing evidence or scope changes may affect the schedule. Sign-off follows an acceptable safety case.
Traceable evidence for review
You receive the full clinical risk management file — CSCR, hazard log, safety requirements, PMS plan and release memo — handed over in a version-tracked folder, traceable end to end and ready for DTAC and trust submission.
The CSO who already knows your product
If we agree ongoing support, I can review changes and emerging hazards with the context from the initial engagement. New uses or major changes may need additional discovery and evidence.
Exactly what's in, and what's not.
Clear boundaries are what keep a fixed fee fixed. The package below is the defined pre-go-live clinical safety work. Anything beyond it is genuinely separate work, scoped and priced on its own — so neither of us is surprised.
- Clinical safety case report (CSCR), DCB 0129-conformant
- Clinical risk management file & hazard log (CRMF)
- One facilitated hazard identification workshop
- Safety requirements specification, mapped to hazards
- Written post-market surveillance plan
- CSO review and release memo, signed where the evidence supports it
- Up to three meetings and two rounds of revisions on the deliverables
- Audit-ready handover in a version-tracked folder
- Running post-market surveillance after go-live
- Safety reviews, incident reviews and hazard log updates post-launch
- Sign-off of major product changes or newly identified hazards
- DTAC and DSPT cross-walks and submissions
- Recurring clinical governance meetings
- Re-work driven by major scope changes mid-engagement
- Standing as named CSO for the deploying organisation under DCB 0160
- Regulatory work beyond DCB 0129 / 0160 (e.g. UKCA/MDR)
Post-go-live work is billed at £125/hr, or by optional monthly retainer. The fixed fee covers the agreed deliverables and revision limits. Additional work, including major scope changes before release, is agreed and priced separately.
Who this service is for
The right fit — and the honest mismatch.
Built for these teams
Digital health and SaMD suppliers preparing for an NHS pilot, procurement review or deployment, who need product-specific DCB 0129 evidence and a clearly appointed CSO.
When I'll point you elsewhere
If your product isn't health IT used within the NHS, if you need a full quality management system or UKCA/MDR conformity rather than DCB clinical safety, or if you need a permanent in-house CSO, I'll say so on the first call — and refer you on where I can.
Timeline and dependencies
A four-week target, with clear dependencies.
The four-week sequence
Discovery & scope
A 90-minute kickoff to review your product, users and deployment context. I confirm the scope, evidence needed and timetable before the agreed work begins.
Hazard workshop
Half-day workshop with your clinical and engineering leads. We work through the hazard log together. By the end you have a populated CRMF.
Drafting
I draft the CSCR, safety requirements and monitoring plan. Your team supplies verification evidence and resolves safety actions, with a short check-in to review progress.
Sign-off
I review the evidence and outstanding actions, then document the clinical safety judgement. Sign-off depends on acceptable residual risk; the completed file is handed over in a version-tracked folder.
One number for the package.
One number for everything else.
The fixed fee covers the agreed pre-go-live scope. Additional work is discussed and priced before it starts, including post-go-live support and material scope changes.
One fixed fee for the agreed pre-go-live clinical safety case: CSCR, CRMF, hazard log, safety requirements spec, post-market surveillance plan, and CSO review and sign-off where the evidence supports it. Target four-week turnaround, up to three meetings and two rounds of revisions.
Priced to put in a board pack with confidence. Excludes post-go-live work (below). Full cost guide →Post-go-live work is not included in the package. Running post-market surveillance, safety reviews after go-live, incident reviews, hazard log updates, sign-off of major product changes or new hazards, DTAC and DSPT cross-walks, and recurring governance meetings are billed hourly, or by optional retainer if you'd prefer a fixed monthly arrangement.
Hours logged transparently. Billed monthly. Named CSO retainer details →Already have a substantially complete safety case? Existing-case review or CSO handover is £125/hour, typically 6–10 hours. Start with a two-hour £250 review, then receive a capped estimate for the remaining work.
Common questions.
What is a Clinical Safety Officer?
A registered clinician, trained in clinical risk management, who is accountable for the clinical safety of a health IT system. DCB 0129 and 0160 require a named CSO to review and sign off the clinical safety case before NHS go-live. I'm a doctor with NHS clinical experience and CSO based in England. Read the CSO explainer →
Do I really need DCB 0129?
DCB 0129 applies to relevant health IT manufacturing activity in England; the deploying organisation has separate DCB 0160 responsibilities. Applicability depends on the product and context. I check that first, before agreeing an engagement.
How fast can this be done?
Target four weeks from an agreed kickoff, subject to evidence readiness, team availability and resolution of safety actions. The fee covers the agreed scope. Sign-off is conditional on the clinical safety evidence and residual risk.
What happens after launch?
The fixed-fee package ends at go-live. Ongoing post-market surveillance, safety reviews after go-live, incident reviews, hazard log maintenance, sign-off of major product changes or new hazards, and recurring governance are not included — they're billed hourly at £125/hr, or by optional retainer. For supplier-side named CSO support, see contract Clinical Safety Officer support; for external or independent CSO language, see independent Clinical Safety Officer.
Start with the practical guides.
Pilot deadline already in the calendar?
Send me the product, the timeline and the trust you're deploying into. I aim to reply within two working days with a next step or, where appropriate, a referral.